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Health Highlights: Sept. 24, 2018
Posted yesterday in Medical
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Device Might Be 'Game Changer' for Patients With Severe Heart Failure A tiny clip may be a big advance for millions of Americans battling severe heart failure, new research announced on Sunday suggests. Researchers say a device, called a mitral clip, inserted into the heart greatly lowered death rates for these... Read more
FDA Approves Copiktra (duvelisib) Capsules for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Follicular Lymphoma
Posted today in New Drug Approvals
BOSTON--(BUSINESS WIRE)--Sep. 24, 2018-- Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, today announced that the U.S. Food and Drug Administration (FDA) has approved Copiktra, an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta... Read more
Short Bout of Exercise Might Boost Your Memory
Posted today in Medical
MONDAY, Sept. 24, 2018 -- Just a little bit of light exercise can immediately improve a person's memory, new Japanese research suggests. How little? The small study involved 36 healthy college-aged men and women and found that just 10 minutes of relaxed cycling on a stationary bike was all it took to improve recall during memory testing conducted right afterwards. Why? Brain scans on 16 of the participants... Read more
Net Benefit of Anticoagulants for A-Fib Varies With Stroke Rate
Posted today in News for Health Professionals
MONDAY, Sept. 24, 2018 -- There is variation in the net clinical benefit of anticoagulants based on variation in published atrial fibrillation (AF) stroke rates, according to a study published online Sept. 25 in the Annals of Internal Medicine. Sachin J. Shah, M.D., M.P.H., from the University of California in San Francisco, and colleagues examined the effect of variation in published AF stroke rates on the net... Read more
Interpreter Services Critical for Emergency Care
Posted today in News for Health Professionals
MONDAY, Sept. 24, 2018 -- Emergency department interpreters are vital to quality care, according to an article published in the October issue of the Annals of Emergency Medicine. Jay M. Brenner, M.D., from the State University of New York Upstate Medical University in Syracuse, and colleagues write that about 8 percent of the U.S. population older than 5 years has limited English proficiency. This language barrier... Read more
Gender Nonconformity Linked to Students' Mental Distress
Posted today in News for Health Professionals
MONDAY, Sept. 24, 2018 -- Gender nonconformity (GNC) is associated with mental distress for female and male students, according to a study published online Sept. 24 in JAMA Pediatrics. Richard Lowry, M.D., from the U.S. Centers for Disease Control and Prevention in Atlanta, and colleagues used data from the Youth Risk Behavior Survey conducted in 2015 to examine the correlations of GNC with mental distress and... Read more
Participation Up With Online Diabetes Prevention Program
Posted today in News for Health Professionals
MONDAY, Sept. 24, 2018 -- For overweight/obese veterans with prediabetes, participation is higher for online Diabetes Prevention Programs (DPPs), but weight loss is similar for online and in-person DPPs, according to a study published online Sept. 24 in the American Journal of Preventive Medicine. Tannaz Moin, M.D., from the VA Greater Los Angeles Health Care System, and colleagues examined online DPP weight loss... Read more
New Risk Factors Identified for Varicose Vein Disease
Posted today in News for Health Professionals
MONDAY, Sept. 24, 2018 -- New risk factors have been identified for varicose vein disease, including height, according to a study published online Sept. 24 in Circulation. Eri Fukaya, M.D., Ph.D., from the Stanford University School of Medicine in California, and colleagues applied machine learning to agnostically search for varicose vein risk factors in a cohort of 493,519 individuals in the U.K. Biobank.... Read more
Gun Victims More Likely to Die Than Other Trauma Patients
Posted today in Medical
MONDAY, Sept. 24, 2018 -- Gunshot wounds are far deadlier than other types of trauma, according to a new study. Gunshot victims are five times more likely to need a blood transfusion. They also require 10 times more blood units than people involved in falls, car accidents, stabbings or other assaults, according to researchers from Johns Hopkins University in Baltimore. And they are 14 times likelier to die than... Read more
Coffee Shop Workers on Front Lines of Opioid Crisis
Posted today in Medical
MONDAY, Sept. 24, 2018 -- New research suggests that employees in coffee shops and fast food places can be trained to respond to opioid overdoses at their places of business. "Because opioid overdoses may occur in public bathrooms, business managers and staff unwittingly become first responders. Providing training to service industry employees on how to respond to an overdose and administer naloxone will help us... Read more
Gender 'Nonconformity' Takes Mental Toll on Teens
Posted today in Medical
MONDAY, Sept. 24, 2018 -- American teens whose behavior, appearance or lifestyle do not conform to widely held views on what it is to be a "normal" male or female face a high risk for mental distress and drug abuse, new research warns. The findings were culled from a national survey exploring the psychological risk profiles of teens who described themselves as "gender nonconforming." The poll enlisted more than... Read more
Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Erdafitinib for the Treatment of Metastatic Urothelial Cancer
Posted 7 days ago in New Drug Applications
HORSHAM, Pa., Sept. 18, 2018 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of erdafitinib for the treatment of patients with locally advanced or metastatic urothelial cancer (UC) and certain fibroblast growth factor receptor (FGFR) genetic alterations... Read more
FDA Approves Ajovy (fremanezumab-vfrm) for Preventive Treatment of Migraine
Posted 10 days ago in New Drug Approvals
September 14, 2018 -- Today, the US Food and Drug Administration (FDA) approved Ajovy (fremanezumab-vfrm) for the preventive treatment of migraine in adults. Ajovy is the second FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule that is involved in migraine attacks. Aimovig (erenumab-aooe), the first in this... Read more
FDA Approves Xelpros (latanoprost ophthalmic emulsion) to Treat Open-angle Glaucoma or Ocular Hypertension
Posted 10 days ago in New Drug Approvals
MUMBAI, India & PRINCETON, N.J.--(BUSINESS WIRE) September 14, 2018 --Sun Pharmaceutical Industries Ltd. and Sun Pharma Advanced Research Company Ltd. (SPARC) today announced U.S. Food and Drug Administration (USFDA) approval for the New Drug Application (NDA) of Xelpros (latanoprost ophthalmic emulsion) 0.005% for the reduction of elevated intraocular pressure (IOP, or pressure inside the eye) in patients with... Read more
Ardelyx Submits New Drug Application for Tenapanor for IBS-C
Posted 11 days ago in New Drug Applications
FREMONT, Calif., Sept. 13, 2018 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting U.S. marketing authorization of tenapanor for the treatment of patients with irritable bowel syndrome with constipation (IBS-C). Tenapanor, Ardelyx's lead product candidate, is a minimally-systemic small molecule that... Read more
FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA)
Posted 11 days ago in New Drug Approvals
South San Francisco, CA -- September 13, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients two years of age and older. Actemra can be given alone or in combination with... Read more
FDA Approves Lumoxiti (moxetumomab pasudotox-tdfk) for Hairy Cell Leukemia
Posted 11 days ago in New Drug Approvals
September 13, 2018 -- The U.S. Food and Drug Administration today approved Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Lumoxiti is a CD22-directed cytotoxin and is the first of this type of... Read more
Acorda Announces FDA Extends Inbrija NDA Review Period
Posted 12 days ago in New Drug Applications
ARDSLEY, N.Y.--(BUSINESS WIRE)--September 13, 2018 -- Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) of Inbrija™ (levodopa inhalation powder) from October 5, 2018 to January 5, 2019. This extension is related to recent submissions Acorda made i... Read more
Janssen Submits Esketamine Nasal Spray New Drug Application to U.S. FDA for Treatment-Resistant Depression
Posted 3 weeks ago in New Drug Applications
September 04, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for esketamine nasal spray. Janssen is seeking FDA approval of esketamine for treatment-resistant depression in adults. Esketamine is an investigational, rapidly acting antidepressant that works differently than... Read more
FDA Issues a Complete Response Letter for New Drug Application for Dasotraline for the Treatment of ADHD
Posted 3 weeks ago in New Drug Applications
MARLBOROUGH, Mass.--(BUSINESS WIRE) August 31, 2018 --Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter for the New Drug Application (NDA) for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), for the treatment of attention-deficit hyperactivity disorder (ADHD). Upon completion of their... Read more
FDA Issues Statement Reaffirming the Positive Benefit-Risk Profile of Nuplazid (pimavanserin) for Patients with Hallucinations and Delusions Associated with Parkinson’s Disease Psychosis
Posted 5 days ago in Clinical Trials
SAN DIEGO--(BUSINESS WIRE)--Sep. 20, 2018-- Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) today announced that the FDA has completed a postmarketing review and issued a clear statement reaffirming the positive benefit-risk profile of Nuplazid (pimavanserin) for patients with Parkinson’s disease psychosis. Nuplazid is the only medicine approved in the United States to treat hallucinations and delusions associated with P... Read more
Iterum Initiates SURE 2 and SURE 3 Phase 3 Clinical Trials of IV and Oral Sulopenem in Complicated Urinary Tract and Complicated Intra-abdominal Infections
Posted 6 days ago in Clinical Trials
DUBLIN, Ireland and CHICAGO, Sept. 18, 2018 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company developing antibiotics against multi-drug resistant pathogens, today announced its initiation of the second and third of three planned Phase 3 clinical trials for sulopenem, Iterum’s lead compound and novel antibiotic for the treatment of gram-negative, multi-drug resistant ... Read more
Positive Barhemsys Phase 3 Treatment Data Published in Anesthesia & Analgesia
Posted 11 days ago in Clinical Trials
Cambridge, UK and Indianapolis, US – 14 September 2018: Acacia Pharma Group plc (“Acacia Pharma”, the “Company”) (EURONEXT: ACPH) announces that data and analyses from its positive Phase 3 clinical trial with Barhemsys (intravenous amisulpride) have been published in the online edition of the leading peer-reviewed journal Anesthesia & Analgesia (Candiotti et al1). Positive headline results were first announced by... Read more
AbbVie Presents Upadacitinib Longer-Term (32-Week) and Patient-Reported Outcomes Data from Phase 2b Atopic Dermatitis Study at 27th European Academy of Dermatology and Venereology (EADV) Congress
Posted 11 days ago in Clinical Trials
NORTH CHICAGO, Ill., Sept. 13, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new results from the ongoing Phase 2b study including longer-term (32-week) efficacy and safety data and patient-reported outcomes data evaluating upadacitinib, an investigational, once-daily oral JAK1-selective inhibitor, in adult patients with moderate to severe atopic... Read more
AbbVie Announces Patient-Reported Outcomes Data from Three Pivotal Phase 3 Studies of Risankizumab, Showing Significant Improvements in Health-Related Quality of Life for Patients with Psoriasis
Posted 11 days ago in Clinical Trials
NORTH CHICAGO, Ill., Sept. 13, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new patient-reported outcomes data from three pivotal Phase 3 trials evaluating risankizumab, an investigational interleukin-23 (IL-23) inhibitor, in adult patients with moderate to severe plaque psoriasis. Across all three trials, patients reported significant improvements in... Read more
